Michael J. Domanski

Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data

BACKGROUNDnNumerous randomised trials have compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) for patients with coronary artery disease. However, no studies have been powered to detect a difference in mortality between the revascularisation strategies.nnnMETHODSnWe did a systematic review up to July 19, 2017, to identify randomised clinical trials comparing CABG with PCI using stents. Eligible studies included patients with multivessel or left main coronary artery disease who did not present with acute myocardial infarction, did PCI with stents (bare-metal or drug-eluting), and had more than 1 year of follow-up for all-cause mortality. In a collaborative, pooled analysis of individual patient data from the identified trials, we estimated all-cause mortality up to 5 years using Kaplan-Meier analyses and compared PCI with CABG using a random-effects Cox proportional-hazards model stratified by trial. Consistency of treatment effect was explored in subgroup analyses, with subgroups defined according to baseline clinical and anatomical characteristics.nnnFINDINGSnWe included 11 randomised trials involving 11u2008518 patients selected by heart teams who were assigned to PCI (n=5753) or to CABG (n=5765). 976 patients died over a mean follow-up of 3·8 years (SD 1·4). Mean Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score was 26·0 (SD 9·5), with 1798 (22·1%) of 8138 patients having a SYNTAX score of 33 or higher. 5 year all-cause mortality was 11·2% after PCI and 9·2% after CABG (hazard ratio [HR] 1·20, 95% CI 1·06-1·37; p=0·0038). 5 year all-cause mortality was significantly different between the interventions in patients with multivessel disease (11·5% after PCI vs 8·9% after CABG; HR 1·28, 95% CI 1·09-1·49; p=0·0019), including in those with diabetes (15·5% vs 10·0%; 1·48, 1·19-1·84; p=0·0004), but not in those without diabetes (8·7% vs 8·0%; 1·08, 0·86-1·36; p=0·49). SYNTAX score had a significant effect on the difference between the interventions in multivessel disease. 5 year all-cause mortality was similar between the interventions in patients with left main disease (10·7% after PCI vs 10·5% after CABG; 1·07, 0·87-1·33; p=0·52), regardless of diabetes status and SYNTAX score.nnnINTERPRETATIONnCABG had a mortality benefit over PCI in patients with multivessel disease, particularly those with diabetes and higher coronary complexity. No benefit for CABG over PCI was seen in patients with left main disease. Longer follow-up is needed to better define mortality differences between the revascularisation strategies.nnnFUNDINGnNone.

Next Steps in Primary Prevention of Coronary Heart Disease: Rationale for and Design of the ECAD Trial

Atherosclerotic cardiovascular disease (ASCVD) events, including coronary heart disease and stroke, are the most frequent cause of death and major disability in the world. Current American College of Cardiology/American Heart Association primary prevention guidelines are mainly on the basis of randomized controlled trials of statin-based low-density lipoprotein cholesterol (LDL-C)-lowering therapy for primary prevention of ASCVD events. Despite the clear demonstration of statin-based LDL-C lowering, substantial 10-year and lifetime risks of incident ASCVD continue. Although the 10-year risk is low in young and middle-aged adults who would not be treated according to current guidelines, they ultimately account for most incident ASCVD. If statin-based LDL-C lowering were initiated in them at an age before complex coronary plaques are common in the population, a substantial reduction in lifetime risk of incident coronary heart disease might be achieved. We examine this hypothesis and introduce the design of a currently recruiting trial to address it. (Eliminate Coronary Artery Disease [ECAD]; NCT02245087).

Associations Between Short or Long Length of Stay and 30-Day Readmission and Mortality in Hospitalized Patients With Heart Failure

OBJECTIVESnThis study sought to examine the associations between heart failure (HF)-related hospital length of stay and 30-day readmissions and HF hospital length of stay and mortality rates.nnnBACKGROUNDnAlthough reducing HF readmission and mortality rates are health care priorities, how HF-related hospital length of stay affects these outcomes is not fully known.nnnMETHODSnA population-level, multicenter cohort study of 58,230 patients with HF (age >65 years) was conducted in Ontario, Canada between April 1, 2003 and March 31,xa02012.nnnRESULTSnWhen length of stay was modeled as continuous variable, its association with the rate of cardiovascular readmission was nonlinear (pxa0< 0.001 for nonlinearity) and U-shaped. When analyzed as a categorical variable, there was a higher rate of cardiovascular readmission for short (1 to 2 days; adjusted hazard ratio [HR]: 1.12; 95% confidence interval [CI]: 1.04 to 1.21; pxa0= 0.003) and long (9 to 14 days; HR: 1.11; 95% CI: 1.04 to 1.19; pxa0= 0.002) lengths of stay as compared with 5 to 6 days (reference). Hospital readmissions for HF demonstrated a similar nonlinear (pxa0= 0.005 for nonlinearity) U-shaped relationship with increased rates for short (HR: 1.15; 95% CI: 1.04 to 1.27; pxa0= 0.006) and long (HR: 1.14; 95% CI: 1.04 to 1.25; pxa0= 0.004) lengths of stay. Noncardiovascular readmissions demonstrated increased rates with long (HR: 1.17; 95% CI: 1.07 to 1.29; pxa0< 0.001) and decreased rates with short (HR: 0.87; 95% CI: 0.79 to 0.96; pxa0= 0.006) lengths of stay (pxa0= 0.53 for nonlinearity). The 30-day mortality risk was highest after a long length of stay (HR: 1.28; 95% CI: 1.14 to 1.43; pxa0< 0.001).nnnCONCLUSIONSnA short length of stay after hospitalization for HF is associated with increased rates of cardiovascular and HF readmissions but lower rates of noncardiovascular readmissions. A long length of stay is associated with increased rates of all types of readmission and mortality.

2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.

This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the U.S. Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials intended to support marketing applications. The writing committee recognizes that these definitions may be used in other types of clinical trials and clinical care processes where appropriate. Use of these definitions at the FDA has enhanced the ability to aggregate data within and across medical product development programs, conduct meta-analyses to evaluate cardiovascular safety, integrate data from multiple trials, and compare effectiveness of drugs andxa0devices. Further study is needed to determine whether prospective data collection using these common definitions improves the design, conduct, and interpretability of the results of clinical trials.

Relation of Post–Coronary Artery Bypass Graft Creatine Kinase-MB Elevations and New Q Waves With Long-Term Cardiovascular Death in Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease

Associations of early creatine phosphokinase-MB (CK-MB) elevation and new Q waves and their association with cardiovascular death (CVD) after coronary artery bypass grafting (CABG) have been reported, but this association has not been studied in a large population of patients with diabetes mellitus. In this study, we examine the association of periprocedural CK-MB elevations and new Q waves with CVD in the Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease trial. Cox proportional hazards regression was used to assess the relation of CK-MB elevations and new Q waves in the first 24xa0hours after procedure and their relation to CVD; logistic regression was used to assess odds ratios of these variables. Hazard ratios, 95% confidence intervals, and p values associated with Wald chi-square test are reported. CK-MB elevation in first 24xa0hours after procedure was independently associated with CVD. CVD hazard increased by 6% (p <0.001) with each multiple of CK-MB above the upper reference limit (URL); odds of new post-CABG Q waves increased by a factor of 1.08 (p <0.001); at 7× CK-MB URL, HR was >2. CK-MB URL multiples of 7, 12, and 15 were associated with new Q-wave odds ratios of 9, 16, and 27 times, respectively (p ≤0.001, C-statistic >0.70). New Q waves were independently associated with survival in the multivariate model only when CK-MB was excluded (pxa0= 0.01). In conclusion, independent associations included (1) CVD and early post-CABG CK-MB elevation; (2) new Q waves with early post-CABG CK-MB elevation; (3) CVD with new Q waves only when CK-MB elevation is excluded from analysis.

Reply: Readmissions and Diuretic Dosing

We thank Dr. Peled for raising an interesting point that is relevant to strategies to reduce heart failure (HF) readmissions. Predicting 30-day readmission for HF has been a significant challenge, with most predictive models demonstrating only modest discrimination. In part, this may be due to the

Dual Antiplatelet Therapy in the Prevention of Recurrent Ischemic Events

Patients with coronary artery disease (CAD) who have a history of myocardial infarction (MI) are at increased risk of MI compared to patients with CAD and no such history [(1)][1]. This results, at least in part, from increased platelet activation of uncertain, but prolonged, duration. The